Clinical Drug Experience Knowledgebase

Criteria

Inclusion Criteria:

Histologically/cytologically proven prostate adenocarcinoma that is unresponsive or refractory to hormone therapy
Patients must have received prior hormonal therapy, defined as castration by orchiectomy and/or luteinizing hormone releasing hormone (LHRH) agonists
Patients must have documented progression detected by PSA increase, physical examination and/or imaging
Patients must have achieved stable pain control for a minimum of seven consecutive days prior to study entry.
Prior radiation therapy (to < 25% of the bone marrow only) is permitted. At least 4 weeks must have elapsed since the completion of radiation therapy and the patient must have recovered from side effects prior to study entry.
Prior surgery is allowed. At least 4 weeks must have elapsed since the completion of surgery
Life expectancy > 3 months
ECOG Performance score of < 2.
Neutrophil count > 1.5 x 109/L (1,500/mm3)
Haemoglobin > 10 g/dL
Platelet count > 100 x 109/L (100,000/mm3)
Total bilirubin < the upper limit of normal (ULN) of the institution
ALT (SGPT) and AST (SGOT) < 1.5 x the ULN of the institution
Calculated creatinine clearance, using Cockroft and Gault formula, >60 mL/min
APTT and PT < 1.5 X ULN
Patients (or legally acceptable representative) must have voluntarily given written informed consent to participate in this study.
Patients must be willing to comply with the scheduled visit, treatment plans, laboratory tests, and other study procedures

Exclusion Criteria:

Prior cytotoxic chemotherapy
Prior isotope therapy (e.g., strontium, samarium)
Prior radiotherapy to >25% of bone marrow (whole pelvic irradiation is not allowed)
Prior treatment with biological response modifiers within the previous 4 weeks
Prior malignancy except the following: adequately treated basal cell or squamous cell skin cancer, or any other cancer from which the patient has been disease-free for > 5 years
Known brain or leptomeningeal involvement
Symptomatic peripheral neuropathy > grade 2 according to the NCI Common Terminology Criteria for Adverse Events v3 (NCI CTCAE v3)
Serious intercurrent medical illness that does not permit adequate follow-up and compliance with the study protocol
History of immune-mediated thrombocytopenia, thrombotic thrombocytopenic purpura or other platelet disease, or laboratory evidence of anti-heparin antibodies
Use of drugs that may inhibit the metabolism of docetaxel (cyclosporin, terfenadine, ketoconazole, erythromycin, troleandomycin) within the previous week or during the study
Concurrent treatment with other experimental drugs. Participation in another clinical trial with any investigational drug within 30 days prior to study screening
Treatment with any other anti-cancer therapy (except LHRH agonists) including any prescribed compounds and/or over-the-counter (OTC) products for the treatment of prostate cancer must be stopped prior to day of enrolment
Treatment with systemic corticosteroids used for reasons other than specified by the protocol must be stopped prior to day of enrolment
Concomitant bisphosphonate therapy is not allowed. Patients already receiving bisphosphonates must be stopped prior to day of enrolment
Concomitant use of aspirin (> 150 mg/day), non-steroidal anti-inflammatory drugs (except specific COX-2 inhibitors), heparin, low molecular weight heparin (LMWH), warfarin (> 1 mg/day) or anti-platelet drugs (abciximab, clopidogrel, dipyridamole, ticlopidine and tirofiban). Low-dose aspirin (≤ 150 mg/day) and low-dose warfarin (≤ 1 mg/day) are permitted as concomitant medications
Treatment with heparin or low molecular weight heparin within the previous two weeks is not permitted
History of allergy and/or hypersensitivity to heparin or other anti-coagulants/thrombolytic agents
History of acute or chronic gastrointestinal bleeding within the last two years, inflammatory bowel disease or other abnormal bleeding tendency
Patients at risk of bleeding due to open wounds or planned surgery
Myocardial infarction, stroke or congestive heart failure within the past three months
Uncontrolled or serious infection within the past four weeks